(324 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical effectiveness of a topical gel used with a laser, with no mention of AI or ML.
No.
The device is indicated for temporary removal of light-colored hair, which is a cosmetic purpose and not a therapeutic one.
No
The device, SNA-001 Silver Photoparticle Topical Gel, is intended for temporary removal of light-colored hair when used with a laser. Its described mechanism involves enhancing laser-induced photothermolysis of hair follicles, indicating a therapeutic or cosmetic purpose, not a diagnostic one.
No
The device description clearly states that SNA-001 is a topical gel containing silver particles, which is a physical substance applied to the skin. This is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary removal of light-colored hair" using a topical gel and a laser. This is a cosmetic/dermatological procedure performed on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a topical gel containing silver particles that absorb laser light to heat and damage hair follicles. This is a physical interaction with the body for a therapeutic/cosmetic purpose, not a test to diagnose a condition or provide information about a patient's health status.
- No mention of diagnostic testing: The entire description focuses on the mechanism of hair removal and the clinical study evaluates the effectiveness of hair reduction. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 nm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.
Product codes
QCY
Device Description
SNA-001 Silver Photoparticle Topical Gel (SNA-001) is used as an accessory to 810 nm diode dermatologic lasers for the removal of unwanted body hair. SNA-001 consists of near-infrared lightabsorbing silver particles suspended in a topical gel that mediates selective photothermolysis of the hair follicle when illuminated by a specific wavelength of laser light (810 nm). The photoparticles are nanoscale silver plates coated with silica and tuned to a wavelength of 810 nm corresponding to commonly used dermatologic lasers. These photoparticles function as highly efficient chromophores for the absorption of laser light. When exposed to laser light of the appropriate wavelength, the photoparticles rapidly heat to temperatures capable of facilitating targeted damage to the hair follicle . SNA-001 is dark blue/black in color, is for single use only, and is provided non-sterile in 1cc polypropylene syringe dispensers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face (upper lip/posterior neck), axilla, or bikini line
Indicated Patient Age Range
Mean age of 45 years.
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multicenter, randomized, within-subject controlled clinical study with blinded assessment was conducted in the U.S. to evaluate the safety and effectiveness of SNA-001 when used as an accessory to 810 nm diode laser for the removal of unwanted light-colored facial and body hair (i.e., white, gray, blonde, light brown, or light red). A total of 77 subjects received treatment and were included in the Safety Population. Treatment and assessment areas on each subject were precisely defined on the left and right sides of one of the following three anatomical areas: face (upper lip/posterior neck), axilla, or bikini line. Of the 77 subjects treated, 65 were included in the Intent to Treat (ITT) Population and 49 were included in the Per Protocol (PP) population.
The primary measure of effectiveness was the mean percentage in hair count from baseline to 3 months post-treatment. Analyses of effectiveness were performed for ITT and PP Populations using observed data, i.e., actual data collected without adjustment for missing values, as well as imputed data, i.e., actual data collected plus estimations for missing values. Multiple imputation (MI) methodology was used to estimate missing values. Statistical comparisons of the two treatments (SNA-001 + laser and Vehicle + laser) were prespecified to include both non-inferiority and superiority assessments.
The primary effectiveness analysis of the difference between treatments met the prespecified non-inferiority criterion for the percentage change in hair count from baseline to 3 months post-treatment using MI for the ITT Population. Furthermore, the mean reduction in hair count was numerically higher for SNA-001 + laser than for Vehicle + laser in both the ITT and PP populations using MI and observed data but the differences were not statistically significant.
In an analysis of the proportion of subjects achieving a defined percentage reduction in hair count (e.g., 10%, 20%, 30%, 40%, etc. reduction) at 3 months, there were generally more subjects achieving the target hair reduction in the SNA-001 + laser group than in the Vehicle + laser group. The differences between the two treatment groups weren't statistically significant except at 50% or greater hair reduction where a significantly greater proportion of subjects in the SNA-001 + laser group than in the Vehicle + laser group achieved the target (17.4% vs 8.7%; p = 0.046).
Safety data analyses demonstrated that treatment with SNA-001 was safe and well tolerated. Most reported adverse events in the treatment area were local dermatologic reactions of mild to moderate intensity, similar to those routinely observed with the use of dermatologic lasers. This included erythema. blistering, scabbing, bruising, rash, and a single report of skin pigmentation changes. These events resolved without sequelae; at 3 months post-treatment, there were no reports of adverse events in the treatment areas.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Percentage Change in Hair Count from Baseline to 3 Months Post-Treatment:
ITT (Observed): SNA-001 + Laser -17.5, Vehicle + Laser -1.1
ITT (MI): SNA-001 + Laser -16.5, Vehicle + Laser -3.6
PP (Observed): SNA-001 + Laser -25.4, Vehicle + Laser -19.7
PP (MI): SNA-001 + Laser -24.6, Vehicle + Laser -13.9
Proportion of subjects achieving 50% or greater hair reduction: SNA-001 + laser group 17.4% vs Vehicle + laser group 8.7% (p = 0.046).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug" in blue, and "Administration" in a smaller font size below.
Sebacia, Inc. Pedro Medrano Acting Head of Regulatory Affairs 2905 Premiere Parkway, Suite 150 Duluth GA 30097
August 12, 2020
Re: K192620
Trade/Device Name: SNA-001 Silver Photoparticle Topical Gel Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: QCY Dated: July 9, 2020 Received: July 16, 2020
Dear Pedro Medrano:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192620
Device Name SNA-001 Silver Photoparticle Topical Gel
Indications for Use (Describe)
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 mm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
510(k) Number: K192620
Submitter:
Sebacia. Inc. 2905 Premiere Parkway, Suite 150 Duluth, GA 30097
Contact: Pedro Medrano Tel: 678-812-1103 Email: pmedrano@sebacia.com
August 12, 2020 Date Prepared:
Device Information:
| Trade Name: | SNA-001 Silver Photoparticle Topical Gel | |
|---|---|---|
| Common Name: | Powered Laser Surgical Instrument | |
| Device Class: | Class II | |
| Classification Name: | Laser Absorbing Particles | |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery and in | |
| dermatology | ||
| Regulation No.: | 878.4810 | |
| Product Code: | QCY | |
| Prior Product Code: | GEX | |
| Predicate Device: | ThermoLase® Softlight Carbon Lotion (K971207) |
Device Description:
SNA-001 Silver Photoparticle Topical Gel (SNA-001) is used as an accessory to 810 nm diode dermatologic lasers for the removal of unwanted body hair. SNA-001 consists of near-infrared lightabsorbing silver particles suspended in a topical gel that mediates selective photothermolysis of the hair follicle when illuminated by a specific wavelength of laser light (810 nm). The photoparticles are nanoscale silver plates coated with silica and tuned to a wavelength of 810 nm corresponding to commonly used dermatologic lasers. These photoparticles function as highly efficient chromophores for the absorption of laser light. When exposed to laser light of the appropriate wavelength, the photoparticles rapidly heat to temperatures capable of facilitating targeted damage to the hair follicle . SNA-001 is dark blue/black in color, is for single use only, and is provided non-sterile in 1cc polypropylene syringe dispensers.
4
Intended Use/Indications for Use:
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 nm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.
Summary of Substantial Equivalence
SNA-001 and its predicate, ThermoLase® Softlight Carbon Lotion, have the same intended use, which encompasses the indication for use, as laser absorbing particles to be used in combination with an 810 nm diode laser for hair removal treatments. In relation to technological characteristics, SNA-001 and Thermolase lotion are comprised of different materials and delivery vehicles but the fundamental physical principle by which the two devices facilitate laser hair removal is identical. Both products are comprised of particles that absorb light from a laser and rapidly heat to temperatures capable of facilitating targeted injury to the hair follicle. As such, they are both chromophores. In dark-colored hair, the natural chromophore is melanin but in the case of light-colored hair, melanin is limited or even absent. SNA-001 acts as an exogenous chromophore to help facilitate the removal of light-colored hair with an 810 nm diode laser. Thermolase lotion is used in the same manner but with a Q-Switched 1064 mm Nd:YAG laser. The differences in technological characteristics are not material to the primary mechanism of action and do not raise additional questions of safety or efficacy as the key question is whether these exogenous particles can safely and effectively facilitate photothermal heating when used with the attendant dermatological laser. The non-clinical and clinical performance data demonstrate that SNA-001 is as safe and effective as the predicate device for its intended use.
Discussion of Performance Data
Non-Clinical Testing
SNA-001 was tested ex vivo for photothermal heating ability, biocompatibility (in accordance with ISO 10993-1), and shelf life. The established shelf life for SNA-001 is 18 months based on real-time stability testing data. A biodistribution study in a porcine model was conducted to evaluate the topication of SNA-001 by vibration-assisted massage, followed by laser treatment, to analyze skin distribution and response. The results of the animal testing demonstrated that SNA-001 meets requirements for functionality and safety. The findings of the non-clinical testing demonstrated that SNA-001 Silver Photoparticle Topical Gel functions as intended, is biocompatible, and is as safe and effective as the predicate device for its intended use.
Clinical Studies
A multicenter, randomized, within-subject controlled clinical study with blinded assessment was conducted in the U.S. to evaluate the safety and effectiveness of SNA-001 when used as an accessory to 810 nm diode laser for the removal of unwanted light-colored facial and body hair (i.e., white, gray, blonde, light brown, or light red). A total of 77 subjects received treatment and were included in the Safety Population. Treatment and assessment areas on each subject were precisely defined on the left and right sides of one of the following three anatomical areas: face (upper lip/posterior neck), axilla, or bikini line. Of the 77 subjects treated, 65 were included in the Intent to Treat (ITT) Population and 49 were included in the Per Protocol (PP) population.
The majority of study subjects were female (96.9%) with a mean age of 45 years. All subjects were white, and the majority were not Hispanic or Latino. The distribution of Fitzpatrick skin type was 9.2% Type I, 61.5% Type II and 29.2% Type III. Subjects with light brown (33.8%) or blonde hair (32.3%) predominated with lesser percentages of subjects having light red (9.2%), white (9.2%), gray (3.1%), or a mixture of light hair colors (12.3%). Approximately 65% of the study subjects had treatment to the face (upper lip/posterior neck), while the remainder had treatment to the axilla (23.1%) or bikini line (12.3%).
The primary measure of effectiveness was the mean percentage in hair count from baseline to 3 months post-treatment. Analyses of effectiveness were performed for ITT and PP Populations using
5
observed data, i.e., actual data collected without adjustment for missing values, as well as imputed data, i.e., actual data collected plus estimations for missing values. Multiple imputation (MI) methodology was used to estimate missing values. Statistical comparisons of the two treatments (SNA-001 + laser and Vehicle + laser) were prespecified to include both non-inferiority and superiority assessments.
The table below summarizes the mean percentage change in hair count from baseline to 3 months posttreatment using a) observed data for the ITT and PP Populations, and b) imputed data for the ITT and PP Populations. The primary effectiveness analysis of the difference between treatments met the prespecified non-inferiority criterion for the percentage change in hair count from baseline to 3 months post-treatment using MI for the ITT Population. Furthermore, the mean reduction in hair count was numerically higher for SNA-001 + laser than for Vehicle + laser in both the ITT and PP populations using MI and observed data but the differences were not statistically significant.
| Analysis Population (Data) | SNA-001 + Laser
(mean % change) | Vehicle + Laser
(mean % change) |
|----------------------------|------------------------------------|------------------------------------|
| ITT (Observed) | -17.5 | -1.1 |
| ITT (MI)* | -16.5 | -3.6 |
| PP (Observed) | -25.4 | -19.7 |
| PP (MI) | -24.6 | -13.9 |
Mean Percentage Change in Hair Count from Baseline to 3 Months Post-Treatment
NOTE: A negative number denotes reduction in hair count from baseline
*The analysis of the difference between treatments demonstrated non-inferiority of SNA-001 + laser to Vehicle + laser
In an analysis of the proportion of subjects achieving a defined percentage reduction in hair count (e.g., 10%, 20%, 30%, 40%, etc. reduction) at 3 months, there were generally more subjects achieving the target hair reduction in the SNA-001 + laser group than in the Vehicle + laser group. The differences between the two treatment groups weren't statistically significant except at 50% or greater hair reduction where a significantly greater proportion of subjects in the SNA-001 + laser group than in the Vehicle + laser group achieved the target (17.4% vs 8.7%; p = 0.046).
Safety data analyses demonstrated that treatment with SNA-001 was safe and well tolerated. Most reported adverse events in the treatment area were local dermatologic reactions of mild to moderate intensity, similar to those routinely observed with the use of dermatologic lasers. This included erythema. blistering, scabbing, bruising, rash, and a single report of skin pigmentation changes. These events resolved without sequelae; at 3 months post-treatment, there were no reports of adverse events in the treatment areas. Other reported adverse events (i.e., not in the treatment areas) were general illnesses, conditions, and complaints unrelated to study treatment. There were no serious and/or unanticipated adverse events related to study treatment.
Overall Conclusion
SNA-001 Photoparticle Topical Gel is indicated for use as an accessory to 810 nm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white. The non-clinical performance data support the substantial equivalence of SNA-001 to the predicate device for the proposed indications.